Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PM HeartIHD prediction.
- Who it may be relevant to
- Registry conditions: Ischemic Heart Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The PM-Heart algorithm (PMHeartIHD) is an in-house developed software that predict the survival prognosis for the individual patient hospitalized with ischemic heart disease (IHD) after a coronary arteriography has been performed. The software is intended to be used as a clinical decision support system i.e. the calculated survival prognosis is expected to enhance the quality of the treating physician's therapeutic considerations concerning (minor) adjustments to the patients treatment and follow-up - all within the framework of the current medical guidelines. Thus, the algorithm does not "show the physician specifically what to do", but rather ensures a better knowledgebase for the overall interpretation and choice of management of the patient.
Detailed description
To investigate the clinical usefulness of the developed clinical decision support system - the PMHeartIHD algorithm - we wish to investigate whether the clinical use of the algorithm will;
* Improve patient prognosis and, * Minimize the risk of re-hospitalization,
compared to patients who are treated without the attending/treating physician knowing the algorithm's prognosis?
Interventions
- Other PM HeartIHD prediction
The calculated prediction and the explainability factors will be made available to the physician, which the physician then can decide to take into his/hers evaluation about further treatment.
Primary outcome measures
- Number and duration of readmissions within one month after randomization [Time frame: From randomization to the study and up to 1 year hereafter]
- Number and cause of death (all-cause mortality) within one year after randomization [Time frame: From randomization to the study and up to 1 year hereafter]
Secondary outcome measures (12)
- Readmission(s) within 30 days of the randomization [Time frame: Up to 30 days after randomization to the study.]
- Cardiovascular readmission(s) within 30 days of the randomization [Time frame: Up to 30 days after randomization to the study.]
- Readmission(s) with acute coronary syndrome [Time frame: From randomization to the study and up to 1 year hereafter]
- One-year survival [Time frame: From randomization to the study and up to 1 year hereafter]
- Total number of days the primary hospitalization lasts [Time frame: From randomization to the study and up to 1 year hereafter]
- Total number of days at the hospital incl. hospitalizations during the first year after inclusion [Time frame: From randomization to the study and up to 1 year hereafter]
- Number of hospitalizations the first year [Time frame: From randomization to the study and up to 1 year hereafter]
- Number and type of performed cardiac investigations [Time frame: From randomization to the study and up to 1 year hereafter]
- Number of cardiac follow-up consultations at the hospital [Time frame: From randomization to the study and up to 1 year hereafter]
- Number of check-ups for cardiovascular reasons at the general practitioner [Time frame: From randomization to the study and up to 1 year hereafter]
- Number of cardiovascular drugs at discharge [Time frame: From randomization to the study and up to 1 year hereafter]
- Dosages (DDD) of drugs at discharge [Time frame: Up to 1 year after randomization to study.]
Eligibility criteria
Inclusion criteria
- Hospitalized patients in one of the involved departments of cardiology (see below) with;
- Ischemic heart disease; the clinical presentation may be stable, worsening/unstable angina, non-ST-elevation myocardial infarction or ST-elevation myocardial infarction, and with - Significant coronary artery lesions or diffuse coronary artery disease on invasive coronary angiography during the admission
Exclusion criteria
- <18 years of age
- Living outside Denmark
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Denmark · 1 center
- Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital. — Copenhagen Ø
Identifiers
NCT: NCT06033014 · p-2023-14244